Immunological Characterization of Blood of Normal Individuals

This study seeks to obtain normal samples of blood, saliva and urine to serve as controls for other approved protocols and for analysis. These include determination of the functional capabilities of cells, proteins, nucleic acids and microvesicles obtained from peripheral blood including plasma, serum and cellular fraction from normal individuals. Saliva and urine will have similar testing which may also be compared to the blood testing results. The ongoing objective varies from investigation to investigation but in general the investigational goals are to better understand the immune function of normal volunteers and compare it to immune function in disease states.

Study Overview

• Status: Completed
• Conditions: Heathly Volunteers
• Intervention / Treatment: Other: No intervention

Detailed Description

Blood will be obtained via peripheral venipuncture. The blood will be divided into components (e.g. plasma, serum, microvesicles, and cells) then analyzed. Flow cytometry will be used to determine cell and microvesicle subsets. RNA will be extracted from the various components of blood and will be subjected to gene and microRNA profiling to determine gene expression. DNA will be isolated from the cells to be used in studies investigating epigenetic regulation of genes identified in the screens. Protein will also be isolated from the multiple components to examine the impact of genetic regulation by epigenetic mechanisms or microRNA on protein expression. Peripheral blood mononuclear cells will be placed in tissue culture for study.

Saliva and urine will be obtained the same day as blood for testing.

• Study Type: Observational
• Enrollment (Actual): 1300

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants may also be recruited by word of mouth or via public advertising. This study is open to all eligibile healthy adult volunteers regardless of gender, age and ethnicity.

Description

Inclusion Criteria:

• Healthy with no chronic or acute illnesses, or taking medication which in the opinion of the PI would impact the analyses being conducted.
• At least 18 years or older.
• Are capable of reading, understanding and providing written informed consent.

Exclusion Criteria:

• Non-English speaking.
• Individuals under 18 years old.
• Woman who believe they are or may be pregnant. (Based on self reporting. Pregnancy testing will not be conducted for the purposes of this study)
• Individuals experiencing acute or chronic illnesses which in the opinion of the PI would impact the analyses being conducted.
• Currently taking prescription or over the counter medication which in the opinion of the PI would impact the analyses being conducted.
• Individual has donated blood more than twice in the last week or the amount to be drawn will exceed the maximum allowance in the last 8 weeks.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteer; Healthy Volunteer without lung disease	Other: No intervention; There is no intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood content differences between the lung disease and healthy control populations	Test for differences in the blood of individuals with lung disease and normal healthy controls.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic expression of relevant genes between the lung disease and healthy control populations	Test for genetic differences in the blood of individuals with lung disease and normal healthy controls.	Day 1
Saliva and urine analysis results compared to blood content results between the lung disease and healthy control populations.	Analyze saliva and urine along with the blood sample in order to compare the information in the blood with the saliva and urine.	Day 1
Identify diagnostic and prognostic indicators for lung disease	Develop and test possible diagnostic and prognostic indicators for various lung diseases.	December 2020
Develop possible treatment for lung disease	Develop and test possible reprogramming of blood cells to promote vessel formation as a way to prevent tumor metastases and modify the progression of specific lung diseases.	December 2020

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Clay Marsh, M.D., Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): January 5, 2015
• Study Completion (Actual): January 5, 2015

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: June 30, 2011
• First Posted (Estimate): July 1, 2011

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2011H0007